Safety, Tolerability and Pharmacokinetics of MK-0873 Following Patch Application in Healthy Participants and Psoriasis Participants (MK-0873-020)

NCT01140061 | Completed Phase 1 Results

• 1 other identifier: 0873-020
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the incidence of erythema and other local cutaneous irritation after administration of MK-0873 by patch or cream formulation in healthy participants and participants with mild psoriasis. Part I and Part II in healthy participants will be initiated prior to Part III in psoriasis participants. The primary hypotheses of the study are: 1) that MK-0873 is safe and well tolerated in healthy participants and participants with psoriasis and 2) that the maximum plasma concentration of MK-0873 is \<20 nM in healthy participants and participants with psoriasis.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (4)

• Number of Participants With an Adverse Event of Erythema in Part I of the Study

  Following topical administration of MK-0873 or matching placebo patches once daily for 21 days, the number of participants with an adverse event of erythema was recorded. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  Up to Day 22 in Part 1

• Mean Maximum Plasma Concentration (Cmax) of MK-0873 Following Topical Administration for 10 Days

  Participant blood samples were collected on Day 11 to determine the Cmax of MK-0873 following topical administration in healthy participants and participants with psoriasis

  Day 11

• Number of Participants With an Adverse Event

  An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  Up to 14 days after last dose of study drug (up to Day 42)

• Number of Participants Who Discontinued Study Medication Due to an Adverse Event

  An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  Up to Day 28

Study Arms (10)

Panel A - MK-0873 5.1 mg

EXPERIMENTAL

In Part I, healthy participants received skin patches containing nothing (plain patch), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg of MK- 0873) once daily for 21 days.

Drug: MK-0873 Patch; Drug: Placebo Patch; Drug: Plain patch

Panel A - Placebo

PLACEBO COMPARATOR

In Part I, healthy participants received skin patches containing nothing (plain patch) or placebo once daily for 10 days.

Drug: Placebo Patch; Drug: Plain patch

Panel B - MK-0873 25 mg

EXPERIMENTAL

In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK- 0873) twice daily for 10 days.

Drug: MK-0873 Cream

Panel B - Placebo

PLACEBO COMPARATOR

In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.

Drug: Placebo Cream

Panel C - MK-0873 100 mg

EXPERIMENTAL

In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.

Drug: MK-0873 Cream

Panel C - Placebo

PLACEBO COMPARATOR

In Part II, healthy participants received skin application of placebo cream once daily for 10 days.

Drug: Placebo Cream

Panel D - MK-0873 200 mg

EXPERIMENTAL

In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.

Drug: MK-0873 Cream

Panel D - Placebo

PLACEBO COMPARATOR

In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.

Drug: Placebo Cream

Panel E and Extension - MK-0873 200 mg

EXPERIMENTAL

In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.

Drug: MK-0873 Cream

Panel E and Extension - Placebo

PLACEBO COMPARATOR

In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.

Drug: Placebo Cream

Interventions

MK-0873 Patch DRUG

MK-0873 skin patches containing 0.05%. 0.5%, or 2% MK-0873

Panel A - MK-0873 5.1 mg

MK-0873 Cream DRUG

MK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873

Panel B - MK-0873 25 mg; Panel C - MK-0873 100 mg; Panel D - MK-0873 200 mg; Panel E and Extension - MK-0873 200 mg

Placebo Patch DRUG

Placebo patches matching MK-0873 0.05%, 0.5%, or 2% patches

Panel A - MK-0873 5.1 mg; Panel A - Placebo

Placebo Cream DRUG

Placebo cream matching MK-0873 0.05%, 0.5%, or 2%

Panel B - Placebo; Panel C - Placebo; Panel D - Placebo; Panel E and Extension - Placebo

Plain patch DRUG

Plain patch containing no MK-0873 or placebo

Panel A - MK-0873 5.1 mg; Panel A - Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Part I, II and III:
• Female participants of reproductive potential must test negative for pregnancy and agree to use two acceptable methods of birth control;
• In good general health;
• Nonsmoker;
• Part III only:
• Has diagnosis of plaque-type psoriasis, and has lesions covering at least 3% of total body surface area;

You may not qualify if:

• Part I, II and III:
• Has a history of stroke, chronic seizures or major neurological disease;
• Has a history of cancer;
• Is a nursing mother;
• Part III only:
• Has nonplaque forms of psoriasis;
• Has current drug-induced psoriasis;
• Has received phototherapy, systemic medications/treatments, or used topical medication that could affect psoriasis;
• Has used any systemic immunosuppressants or biologics within the past 4 weeks.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 9, 2010
• Study Start: May 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: February 8, 2019
• Results First Posted: December 12, 2014

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share